Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2025-08-15

Brief Summary

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This study is designed to evaluate the effect of early albumin transfusion within massive transfusion protocol on fluid balance and reduced requirement of transfusion.

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Detailed Description

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Eligible patients who require massive transfusion will be randomized in a single-blind manner (participant) in a 1:1 ratio to Conventional Massive Transfusion Pro. tocol group (C-MTP) or Albumin Massive Transfusion Protocol group (A-MTP). When MTP is initiated according to the result of randomization, all patients(or a legal guardian) are informed about the study and potential risks and benefits. Study will be continued only in patients who give informed consent.

Conditions

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Bleeding Massive Hemorrhage Massive Transfusion Protocol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Albumin-massive transfusion protocol

At the initiation of MTP, 200ml of 20% albumin will be infused followed by transfusion of packed RBC:FFP:Platelet concentrate with ratio of 1:1:1.

Group Type EXPERIMENTAL

Albumin solution

Intervention Type DRUG

200ml of 20% Human Serum Albumin

Conventional-massive transfusion protocol

At the initiation of MTP, Balanced crystalloid will be infused followed by transfusion of packed RBC:FFP:Platelet concentrate with ratio of 1:1:1. Albumin will be transfused according to the serum albumin level.

Group Type ACTIVE_COMPARATOR

Balanced crystalloid solution

Intervention Type DRUG

Balanced crystalloid solution

Interventions

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Albumin solution

200ml of 20% Human Serum Albumin

Intervention Type DRUG

Balanced crystalloid solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients (19 or older)
* Admitted or planned to admit surgical intensive care unit
* Patients with decreased hemoglobin level more than 20% from baseline within 12 hours, Or
* Patients who are suspected bleeding and hemodynamically unstable requiring more than 0.05mcg/kg/min of norepinephrine infusion to maintain mean blood pressure higher than 65mmHg

Exclusion Criteria

* Contraindicated to albumin product
* patients with risk factors of increased circulatory volume (heart failure, pulmonary edema, end-stage renal disease with oliguria)
* patients with hemolytic anemia
* History of anaphylactic reaction to blood product

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No